The Effects of Treating Insomnia Prior to a Weight Loss Intervention in Women With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percent Weight loss
研究概览
简要总结
This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.
详细描述
Participants are women with a diagnosis of early stage breast cancer (ESBC), a BMI ≥25, and insomnia. A total of 30 participants will be randomized to either cognitive behavioral therapy for insomnia and behavioral weight loss (CBT-I+BWL) or a sleep education program and behavioral weight loss (EDU+BWL). Measures will be collected at baseline, 8 weeks (after the CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be % total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed.
The sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person, followed by 4 phone or videoconferencing sessions), and the BWL intervention includes 15 sessions over 6 months (1 in-person, 14 by phone or videoconference). Participants will be given physical activity trackers and will use a dietary app to record their food intake. There are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month follow up, 6-month follow up). These assessment visits are coordinated with in-person sleep and weight loss intervention visits. Some of the measures that will be recorded throughout the study include: height, weight, anthropometric measures (waist/hip measurements), sleep diaries, and self-report measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Participants will not be blinded to the intervention assignment. However, data collection of anthropometric measurements (including height, weight, hip and waist circumference) will be done by a study member blinded to the randomization. Since participants will be aware of their intervention assignment, there are no anticipated circumstances for breaking the blinding or planned procedures for breaking the blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Histologically-confirmed ductal carcinoma in-situ (DCIS) or stage I-III invasive carcinoma of the breast
- •Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
- •Willing to lose 10% of body weight
- •Diagnosed with current breast cancer >3 and <60 months from planned baseline visit date
- •Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within >3 prior to enrollment
- •Diagnosed with insomnia or reports sleep problems
- •Has daily access to the internet and/or smartphone
排除标准
- •Serious/uncontrolled condition likely to hinder accurate measurement of weight or sleep, such as bipolar I, seizure disorders, autoimmune disease, etc., or a medical condition that makes physical activity unsafe
- •Current use of weight loss medications or sleeping aids
- •Current enrollment in a sleep or weight loss program
- •Sleep disorder other than insomnia
- •Plan to become pregnant within next 12 months, or lactating
结局指标
主要结局
Percent Weight loss
时间窗: Change from Baseline, 8 weeks, 3 months and 6 months
The primary outcome will be percent (%) weight loss. All subjects who are randomized will be included in the analysis of the primary outcome. Weight will be measured according to standardized BMI and anthropometric procedures (hip/waist ratio). For the primary aim, comparing the effects of CBT-I+BWL and EDU+BWL on % weight loss at 3 and 6 months, we will model outcomes (at 3 months \& 6 mos.) as a function of baseline level, treatment assignment, time, and their interaction. The interaction term represents the between-group difference in change over time on the outcome.
次要结局
- Sleep continuity as measured by wake after sleep onset (WASO)(Change from Baseline, 8 weeks, 3 months and 6 months)
- Sleep continuity as measured by sleep efficiency (SE)(Change from Baseline, 8 weeks, 3 months and 6 months)
- Sleep continuity as measured by total sleep time (TST)(Change from Baseline, 8 weeks, 3 months and 6 months)
- Sleep continuity as measured by sleep latency (SL)(Change from Baseline, 8 weeks, 3 months and 6 months)